We aimed to test the effect of a sedentary behavior change smartphone app (Vire app and ToDo-CR program) as an adjunct to cardiac rehabilitation on hospital admissions and emergency department (ED) presentations over 12 months.
A multicenter, randomized controlled trial was conducted with 120 participants recruited from 3 cardiac rehabilitation programs. Participants were randomized 1:1 to cardiac rehabilitation plus the fully automated 6-month Vire app and ToDo-CR program (intervention) or usual care (control). The primary outcome was nonelective hospital admissions and ED presentations over 12 months. Secondary outcomes including accelerometer-measured sedentary behavior, BMI, waist circumference, and quality of life were recorded at baseline and 6 and 12 months. Logistic regression models were used to analyze the primary outcome, and linear mixed-effects models were used to analyze secondary outcomes. Data on intervention and hospital admission costs were collected, and the incremental cost-effectiveness ratios (ICERs) were calculated.
Participants were, on average, aged 62 (SD 10) years, and the majority were male (93/120, 77.5%). The intervention group were more likely to experience all-cause (odds ratio [OR] 1.54, 95% CI 0.58-4.10; P=.39) and cardiac-related (OR 3.26, 95% CI 0.84-12.55; P=.09) hospital admissions and ED presentations (OR 2.07, 95% CI 0.89-4.77; P=.09) than the control group. Despite this, cardiac-related hospital admission costs were lower in the intervention group over 12 months (Aus $252.40 vs Aus $859.38; P=.24; a currency exchange rate of Aus $1=US $0.69 is applicable). There were no significant between-group differences in sedentary behavior minutes per day over 12 months, although the intervention group completed 22 minutes less than the control group (95% CI -22.80 to 66.69; P=.33; Cohen d=0.21). The intervention group had a lower BMI (β=1.62; P=.05), waist circumference (β=5.81; P=.01), waist-to-hip ratio (β=.03, P=.03), and quality of life (β=3.30; P=.05) than the control group. The intervention was more effective but more costly in reducing sedentary behavior (ICER Aus $351.77) and anxiety (ICER Aus $10,987.71) at 12 months. The intervention was also more effective yet costly in increasing quality of life (ICER Aus $93,395.50) at 12 months.
The Vire app and ToDo-CR program was not an outcome-effective or cost-effective solution to reduce all-cause hospital admissions or ED presentations in cardiac rehabilitation compared with usual care. Smartphone apps that target sedentary behavior alone may not be an effective solution for cardiac rehabilitation participants to reduce hospital admissions and sedentary behavior.
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123.
RR2-10.1136/bmjopen-2020-040479.
目的:我们旨在测试久坐行为改变智能手机应用程序(Vire应用程序和ToDo-CR程序)作为心脏康复的辅助手段在12个月以上的住院和急诊科(ED)报告中的效果。
方法:多中心,我们对来自3个心脏康复项目的120名参与者进行了随机对照试验.参与者被随机分为1:1,接受心脏康复治疗,再加上全自动的6个月Vire应用程序和ToDo-CR计划(干预)或常规护理(对照)。主要结果是非选择性住院和超过12个月的ED报告。次要结果包括加速度计测量的久坐行为,BMI,腰围,在基线和6个月和12个月时记录生活质量.Logistic回归模型用于分析主要结果,和线性混合效应模型用于分析次要结局.收集了干预措施和入院费用的数据,并计算增量成本效益比(ICER)。
结果:参与者是,平均而言,62岁(SD10岁),大多数为男性(93/120,77.5%)。与对照组相比,干预组更有可能经历全因(比值比[OR]1.54,95%CI0.58-4.10;P=.39)和心脏相关(OR3.26,95%CI0.84-12.55;P=.09)住院和ED报告(OR2.07,95%CI0.89-4.77;P=.09)。尽管如此,在12个月内,干预组的心脏相关入院费用较低(252.40澳元vs859.38澳元;P=.24;汇率为1澳元=0.69美元).在12个月内,每天久坐行为分钟数没有显著的组间差异,尽管干预组比对照组完成时间少22分钟(95%CI-22.80~66.69;P=0.33;Cohend=0.21).干预组的BMI较低(β=1.62;P=0.05)。腰围(β=5.81;P=0.01),腰臀比(β=.03,P=.03),生活质量(β=3.30;P=0.05)优于对照组。干预措施在12个月时更有效,但在减少久坐行为(ICERAus$351.77)和焦虑(ICERAus$10,987.71)方面成本更高。在12个月时,干预措施在提高生活质量方面也更有效,但成本更高(ICER澳元93,395.50美元)。
结论:与常规护理相比,Vire应用程序和ToDo-CR计划并不是一种具有结果效益或成本效益的解决方案,可以减少心脏康复中的全因住院或ED表现。仅针对久坐行为的智能手机应用程序可能不是心脏康复参与者减少住院和久坐行为的有效解决方案。
背景:澳大利亚新西兰临床试验注册中心(ANZCTR)ACTRN12619001223123;https://australianclinicaltrials.gov。au/anzctr/trial/ACTRN12619001223123。
■RR2-10.1136/bmjopen-2020-040479。